NCT01491724

Brief Summary

The Learning Curve of Probe-based Confocal Laser Endomicroscopy (pCLE) images interpretation in Gastric Intestinal Metaplasia (GIM) Objective: The aim of this study is to evaluate the learning curve of pCLE images interpretation in GIM. Research design: Blinded review of pCLE images for the diagnosis of GIM Sample size: Five beginner endoscopists will be assigned in this study to read approximately 80 videoclips Data analysis: ROC curve is analyzed by SPSS version 16. Expected Benefit and Clinical Application Information on the learning curve for GIM interpretation from pCLE images in order to develop early gastric cancer detection

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 14, 2011

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

December 15, 2011

Status Verified

December 1, 2011

Enrollment Period

4 months

First QC Date

December 5, 2011

Last Update Submit

December 14, 2011

Conditions

Gastric Intestinal Metaplasia

Outcome Measures

Primary Outcomes (1)

  • The change of accuracy of pCLE images interpretation in GIM after each examination

    Percentage of accuracy changing in each examination

    Baseline and every 2 weeks for 4 sessions

Study Arms (1)

pCLE images

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

5 beginner endoscopists who never had the experience in pCLE

You may qualify if:

  • First year fellow of gastroenterologist who never have the experienced in pCLE interpretation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rapat Pittayanon

Bangkok, Bangkok, 10330, Thailand

RECRUITING

Related Links

Study Officials

  • Rungsun Rerknimitr, Professor

    King Chulalongkorn Memorial Hospital

    STUDY DIRECTOR

  • Rapat Pittayanon, MD

    King Chulalongkron Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rapat Pittayanon, MD

CONTACT

66813132112Rapat125@gmail.com

Nuttaphat Namjud, M.Sc.

CONTACT

66894971957ampere_nut@hotmail.com

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

December 5, 2011

First Posted

December 14, 2011

Study Start

September 1, 2011

Primary Completion

January 1, 2012

Study Completion

April 1, 2012

Last Updated

December 15, 2011

Record last verified: 2011-12

Locations

TH(1)